3rd European Conference on Clinical Research Flying to 2020: Managing Turbulences of Innovation and Change
© CzechTourism.com / Author: Libor Sváček
2020
17 – 18 October 2016, Prague, Czech Republic www.eucrof-conference.eu
Programme Book
Organised by
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Content Welcome Letters
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Organisers 4 Conference Topics
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Conference Information
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Scientific Programme
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Speakers 10 Moderators 29 Floorplan 32 Company Profiles
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Practical Information
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List of Participants
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Partners Acknowledgment
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Welcome Letters Dear Colleagues, Here we are: the third EUCROF International Conference on Clinical Research is on our agenda and so many things have changed since when we had the first one in Brussels in 2013. The amount of work delegated by pharmaceutical and biotech industry to CROs has continued to grow while many believed that it had reached a plateau. The new Clinical Trial Regulation has been adopted and EUCROF has been called to contribute to the design and testing of the EU Portal through which all European clinical trials will be processed. The rules on the timing for publication of results have been discussed and EUCROF has strongly – and successfully – supported an extension of the publication timeline for early phase studies. An accident with severe consequences for healthy volunteers in a phase I study has saddened our horizon and we look forward to contribute to the discussion for reasonable new rules to further protect patients and healthy volunteers involved in clinical trials, particularly in early phases and with very innovative products. For the future we will all face many new challenges and the increasing collaboration spirit between all stakeholders is a very encouraging movement we are witnessing. This Conference aims for a serious professional reflection on where we are and where we are going. With this objective in mind, our Program Committee has carefully selected the topics and the speakers. The outcome is a high profile program offering great opportunity to learn directly from the protagonists as to where clinical research in general, and in particular in Europe, is moving to. Regulatory authorities, pharmaceutical and biotech industries, contract research organisations, patient associations as well as academic groups are all represented at this conference thus facilitating an easy interaction between all stakeholders. Putting speakers and participants on the same level will encourage lively Q&A sessions without cultural barriers. Furthermore, the EUCROF Conference represents a great opportunity to network with all actors involved in all roles of drug and device development. Rapid changes in our working environment require continuous and accurate updates even for those with long accrued experience. Open mindedness is the approach we invite the participants of our Conference to maintain. While the safety of patients remains the centre of our attention we increasingly focus on those aspects which really matter to our patients by using patient reported outcomes as the basis to support marketing authorisations for new treatments. The EUCROF Conference has the ambition to cover all these and other hot topics and to create, for two intense days, the best possible conditions for cultural exchange and knowledge transfer. I sincerely wish you an enjoyable time in Prague in the frame of our Conference and I express a special thank you for the added value your presence will certainly bring to the Conference. Stefano Marini EUCROF President
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Dear Colleagues, Dear Friends, It is a great pleasure to welcome you to the EUCROF International Conference. This is the third time we meet to discuss the current situation, as well as future changes in the organisation of clinical trials. The world is evolving rapidly and the drug development is characterised by many new appeals from both an ethical and legislative points of view. As for the previous two conferences, the organisers are working hard in order to offer all participants with the most important and challenging news from the clinical research, presented by highly experienced speakers coming from all over the world. This year, the national Czech CRO Association ACRO-CZ is honoured to be the organizer and host for the 3rd EUCROF International Conference 2016. We are proud to present you the results of our work in one of the most beautiful cities in the world. I hope you have a fruitful and pleasant stay in Prague and thank you for having chosen to participate in this interesting event.
© CzechTourism.com / Libor Sváček
Petr Janda ACRO-CZ President
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Organisers Programme Committee • Dr. Darina Hrdličková, EUCROF Board Secretary, Director, Clinical Management, PPD • Dr. Michèle Garot, Consultant, Belgium – Former Executive Director, Business Quality and Strategic Liaison, Quintiles • Dr. Dagmar Chase, Vice-President EUCROF, Managing Director Clinrex GmbH • Dr. Alena Hynštová, Sr. Country Manager – SIA Czech Republic & Slovakia, EMEA Site Intelligence and Activation, PPD • Dr. Martine Dehlinger-Kremer, Vice President Global Medical and Regulatory Affairs, SynteractHCR • Dr. Georg Mathis, President & CEO Appletree CI Group AG • Dr. Ivo Šimůnek, Senior Regulatory Submissions Manager, Medpace Czech Republic s. r. o
EUCROF
ACRO-CZ
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Dr. Stefano Marini, President (Italy) Dr. Dagmar Chase, Vice-President (Germany) Yoanni Th. Matsakis, Treasurer (France) Dr. Darina Hrdličková, Secretary (Czech Republic) • Christophe Golenvaux, Member (Belgium)
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The objective of EUCROF (the European CRO Fe deration), a non-profit organisation founded in 2005, is to promote Clinical Research by improving the knowledge, competence/ expertise and skills of Contract/Clinical Research Organisations (CROs) in Europe. The Federation represents and supports the interest of CROs in Europe, towards regulatory bodies, the pharmaceutical, biotech, medical device and other healthcare related industry within the field of clinical research, as well as the medical and affiliated research community. Organising and supporting training and educational programmes will increase the quality of clinical research and improve the collaboration and interaction amongst all stakeholders in the field of Clinical Research in Europe. Active participation to international congresses and meetings will further underline the significant role of CROs in Clinical Research in Europe. Regulatory Authorities recognise EUCROF as the representative for European based CROs, regularly calling EUCROF to contribute to the neverending debate on the improvement of rules and regulations.
ACRO-CZ is a professional association of Contract Research Organizations (CRO) in the Czech Republic, which focuses on clinical research and development of pharmaceuticals. Corporate bodies and individuals can become members of the association. The association was founded in 2005 and it is a member of the European federation of CRO’s – EUCROF. The main goal of the association is to represent CRO’s in conceptual negotiations with state authorities and institutions, as well as internationally, to actively participate in discussions regarding the creation of legal and ethical norms in the area of clinical research, and to create conditions for further education of its members, as well as to develop cooperation in the area of clinical evaluation of pharmaceuticals and to enable arranging contacts also on the international sphere.
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PharmD. Robert Chudáček Dr. Darina Hrdličková PhDr. Viktoria Molnárová Mgr. Martina Šťastná Dr. Dana Vaňková Irena Vorlová, Msc
Conference Topics • • • • • • •
Regulatory News: EU Regulation 536/2014 and ICH-GCP Addendum The Internet of Things and new paradigms in clinical research Post-Marketing Approaches Quality by Design Clinical Trials in the Paediatric Population Clinical Trials with Medical Devices Patient-centric Approach
Conference Information Conference Venue
B2B Meetings
Prague Congress Centre Address: 5. kvetna 65, Prague 4 Meeting rooms are located on the 1st floor, entrance no. 4.
Registered delegates had an opportunity to organize private meetings with other participants via on-line registration form. These pre-arranged meetings are held in Club D.
Registration Desk
Conference Dinner Monday, 17 October, 19:00 – 23:00 Location: Restaurant Zoom (Prague Congress Centre, 1st floor) Dress code: smart casual Price: 75 EUR Spend the evening with the fellow participants to exchange your thoughts and new experiences during informal occasion at Restaurant Zoom with superb view to historical part of Prague, excellent food, local wine and beer and professional dance performance of Standard and Latin‑American style. Moreover you will be invited to join our dancers on the dance floor! If you would like to attend the dinner, please ask Registration staff if tickets are still available.
Registration desk is located on the 1 floor of Prague Congress Centre st
Monday, 17 October Tuesday, 18 October
11:30 – 19:00 8:30 – 16:30
Telephone number to registration desk: +420 725 946 450.
Registration Fee Includes • • • •
Admission to all sessions Admission to Exhibition Area Conference materials Coffee Breaks and Lunch
Please note that the Conference Dinner is not included in the registration fee. In case of your interest please contact Registration Desk.
Conference Badges Delegates are kindly requested to wear their badge at all meetings and official conference functions.
Language The conference language is English. No interpretation is provided.
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Scientific Programme 17 October 2016 10:00–11:30
Press Morning
11:30
Exhibition Opening
11:30–12:30
Registration & Welcome Coffee Break
1st Session: Opening of the Conference (Panorama Hall) 12:30–12:45
12:45–13:30
Welcome Message Dr. Stefano Marini President EUCROF Key Note Speech: Flying to 2020: Managing Turbulences of Innovation and Change Michael Engsig Executive Director, Clinical Management Central and Eastern Europe, PPD
2nd Afternoon Session: Regulatory News: EU Regulation 536/2014 and ICH-GCP Addendum (Panorama Hall) Moderators: Dr. Dagmar Chase, Vice-President EUCROF, Managing Director Clinrex GmbH, Dr. Ulrike Lorch, Medical Director, Richmond Pharmacology, Ltd. 13:30–13:55
13:55–14:20
Regulation 536/2014: Status Quo from EFPIA Perspective Sini Eskola Director, Regulatory Affairs; EFPIA – European Federation of Pharmaceutical Industries and Associations The EU Portal: A Gate to Simplified Clinical Research? Anabela Marçal Head of Committees and Inspections Department, Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicines Agency (EMA)
14:20–14:40
Coffee Break
14:40–15:05
Transparency in Clinical Research of Medicinal Products: Pre and Post Marketing Authorisation Dr. Holger Maria Rohde Director, Strategy Implementation Lead Merck Serono | Strategy and Business Operations Global R&D
15:05–15:35
Discussion
15:35–16:20
ICH-GCP Addendum (including Discussion) Gabriele Schwarz, PharmD Head of GCP Inspectorate, German Federal Institute for Drugs and Medical Devices
16:20–16:40
Coffee Break
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3rd Afternoon Parallel Sessions: The Internet of Things and New Paradigms in Clinical Research (Panorama Hall) Moderator: Yoanni Th. Matsakis President TELEMEDICINE TECHNOLOGIES S.A.A
Post-Marketing Approaches (Club E) Moderator: Xavier Fournie M.D. Corporate Medical Director, Executive Vice‑President, Global Medical Affairs – Real World Evidence, Mapi Group
From Pharma to Health Laboratories: How the Internet of Things is Changing the Way of Delivering Treatments Dr. Vincent Varlet, MD, MBA, INSEAD Executive Consultant www.varlet.paris – business transformation for healthcare companies Cloud Services, Internet of Things, Independent Third Party: New Opportunities for CROs? Alan Yeomans Quality Manager, PCG Solution; representing EUCROF WG on NT
16:40–17:05
Non-interventional Studies: Different Types – Different Challenges Giovanni Fiori, PhD, MPH President and Scientific Director, MEDINEOS Observational Research, Italy
17:05–17:30
17:10–17:25
The Convergence of E-health & Clinical Research Reshaping the Stakeholders' Landscape Yoanni Th. Matsakis, President TELEMEDICINE TECHNOLOGIES S.A.S., France
17:30–17:55
17:25–17:40
Innovative ICT Architecture with Modular Integrated Component for New Study Profile: SPRINTT Study ICT Structure Eng. Gianluca Zia CEO, Caretek s.r.l., Torino, Italy
17:55–18:15
Considerations on ENCePP and Best Pharmacoepidemiology Methods for PASS Prof. Nicholas Moore, MD, PhD, FRCP (Edin), FISPE Head of Pharmacology Department of the University of Bordeaux; Head of Clinical Research of the University Hospital of Bordeaux; President of the International Society of Pharmacovigilance; Member of the Advisory board of ENCePP, France Interventional Vs. Non‑Interventional Study Classification in the European Union: Would my Study Remain Non-Interventional if I use Directto-Patient Contact Methods? Xavier Fournie M.D. Corporate Medical Director, Executive Vice‑President, Global Medical Affairs – Real World Evidence, Mapi Group Discussion
17:40–18:10
Discussion
19:00
Conference Dinner
16:40–16:55
16:55–17:10
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18 October 2016 1st Morning Session: Quality by Design (Panorama Hall) Moderator: Dr. Michèle Garot, Consultant, Belgium – Former Executive Director, Business Quality and Strategic Liaison, Quintiles 9:00–9:25
9:25–9:50
9:50–10:15
Risk Based Monitoring, is the Reality Matching the Model? Andy Lawton Consultant, Former Global Head of Clinical Data Management, Boehringer Ingelheim Ltd, Germany Any Pitfalls in RBM Implementation? The Perspective of the Regulators Gabriele Schwarz, PharmD Head of GCP Inspectorate, German Federal Institute for Drugs and Medical Devices Risk-based Monitoring, Trends in the Model Implementation Dr. Yvonne Rollinger Managing Director, OmniComm Europe GmbH, Bonn, Germany
10:15–10:45
Discussion
10:45–11:15
Coffee Break
2nd Noon Parallel Sessions:
11:15–11:40
11:40–12:05
12:05–12:30
Clinical Trials in the Paediatric Population (Panorama Hall) Moderator: Dr. Martine Dehlinger-Kremer Vice President Global Medical and Regulatory Affairs, SynteractHCR; Chair of the Paediatric Working Group, EUCROF
Clinical Trials with Medical Devices (Club E) Moderator: Dr. Georg Mathis President & CEO Appletree CI Group AG
Regulatory Situation 9 Years After the Implementation of the Paediatric Regulation Dr. Christoph Male, MD, MSc Former Member of the PDCO at EMA and Associate Professor of Paediatrics, Department of Paediatrics, Division of Paediatric Cardiology, Medical University of Vienna, Austria The Role of Paediatric Networks and Benefits in Paediatric Research Mark Turner Chair of the European Network for Paediatric Research at EMA, University, Liverpool, UK Feasibility and Challenges with Paediatric Clinical Trials Dr. Martine Dehlinger-Kremer Vice President Global Medical and Regulatory Affairs, SynteractHCR; Chair of the Paediatric Working Group, EUCROF
The New EU Medical Device Regulation – How Will it Change Our Lives? Shayesteh Fürst-Ladani Managing Director SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland
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Challenges of Clinical Research in the Surgical Field – How to Generate Clinical Evidence? Ivo Schauwecker Clinical Studies Manager, AO Foundation, Switzerland Specific Considerations of In Vitro Diagnostics Jorunn Tverland Clinical Trial Manager, Dako, Agilent Technologies, Denmark
12:30–12:50
Discussion
12:50–14:15
Lunch Break
Discussion
3rd Afternoon Session: Patient-centric Approach (Panorama Hall) Moderator: Dr. Darina Hrdličková, Director, Clinical Management, PPD Czech Republic, s. r. o. 14:15–14:40
14:40–15:05
15:05–15:30
15:30–15:55
Patient Centric Approaches – An Overview Ingrid Klingmann, MD, PhD, FFPM, FBCPM Chairman at EFGCP, President at PharmaTrain Federation asbl, Managing Director at Pharmaplex bvba, Belgium Personalized Medicine: With Big Data to Better Health? Prof. Dr. Horst Domdey Managing Director, BioM Biotech Cluster Development GmbH Geschäftsführer, Germany Data Privacy Isabelle Abousahl Entrepreneur, Alcoam by design; Former Director Data Management, Deputy Biometry, Global Drug Development, Ipsen Innovation, France Big Data-Big Opportunity for Patient Associations and Clinical Trial Center Prof. Giuseppe Banfi, MD, PhD General Manager, San Raffaele Foundation, Italy
15:55–16:10
Discussion
16:10–16:15
Closing Address Dr. Stefano Marini President EUCROF
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Speakers Isabelle Abousahl
Entrepreneur, Alcoam by design; Former Director Data Management, Deputy Biometry, Global Drug Development, Ipsen Innovation, France Isabelle Abousahl-Chaunu has about 25 years of managerial experience and leadership role within Clinical Research organisations, more specifically in the following functions: Clinical Pharmacology; Clinical Operations; Drug Development Resource Planning; R&D Data Management. She has developed over years an expertise in clinical studies, from phase 1 to real world studies, including the registration process for market authorisation in various geographies. Engineer by background, she has developed a strong expertise in data management and eClinical information systems. Isabelle is a certified Data Privacy Professional for Europe, continuing her cursus in Privacy Program Management and Privacy IT. After many years of employment in the pharmaceutical industry (Novartis, Phase Forward, Sanofi and Ipsen), her objective is now to use her experience and skills to advance a new generation of clinical data solutions, supporting the innovation in clinical research, with a strong focus on clinical research site needs, and protective of the patient rights. She is the founder and owner of a new company: “alcoam by design” which aims at providing “data solutions for intelligent drug development”.
Lecture: Data Privacy
Tuesday, 18 October, 15:05 – 15:30 Data privacy may seem at first glance a topic to be addressed and, considering the level of complexity it may have in an international – even European – context, to be sorted out by specialist lawyers. However, beyond regulatory compliance, the protection of personal data from patients and subjects participating into clinical research projects, is one of the keys that allows to overcome the barriers that are currently faced by innovators. As a matter of fact, it contributes to building the trust from public, which is paramount in order to get active participation from persons when it comes to: • Recruiting patients into clinical trials • Recruiting donors for bio-banking projects • Making secondary use of healthcare data for research purposes • Delivering digital applications to patients In parallel, the demand for public clinical trial data disclosure is growing, calling for safeguards to data privacy before making the data available. Even though this might be as per a requirement from regulators, this remains under the responsibility of the sponsors of clinical research projects, and constitutes an ethical commitment as well. “Privacy by Design” is a concept imposed by the new EU General Data Protection Regulation (GDPR), which will have to start being applied as of May, 25th 2018. It means that privacy and protection of personal data is no longer an after-thought, and should be instilled in the practices from clinical development teams from the project onset. Changing the mind-set from people to embrace this concept proceeds from the same small cultural revolution as getting them to embrace the concept of Quality by Design. We will learn that the topic is however easily accessible to everyone, providing that: • The main differences between the type of laws adopted throughout the world are understood • Some basic definitions are known • A general culture regarding data privacy / data protection principles is developed We present the specifics of implementing data protection in the context of GCP studies, public clinical trial data disclosure and secondary use of healthcare data. We shed a light on these topics by making use of real life experience. For instance, the importance of mastering the data flow from clinical study data will be highlighted from the lessons learnt after the invalidation of the Safe Harbor agreement between EU and US by the European Court of Justice, and its recent replacement by the new EU-US Privacy Shield framework for transatlantic data flows.
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Prof. Giuseppe Banfi, MD, PhD
General Manager of San Raffaele Foundation, Italy He was graduated cum laude in Medicine and Surgery on 1984 at University of Pavia and postgraduated in Public Health on 1988 at University of Milan. He had wide work experience in laboratory medicine department in the Scientific Institute San Raffaele Hospital and in direction of hospitals at S. Maria Clinic, Institute Villa Aprica (Como) and, finally, at Galeazzi Orthopedic Institute in Milan. He was Professor of Clinical Biochemistry and Clinical Molecular Biology at School of Medicine at University of University of Milano from 2006 to 2014 and now at University Vita-Salute San Raffaele. Management skills: • Director of Scientific Research programs at IRCCS, (Scientific and Teaching Hospital) Galeazzi Orthopaedic Institute from May 2007 • Director of Scientific Research programs at Gruppo Ospedaliero San Donato Foundation from September 2008 • General Director of Fondazione Centro San Raffaele from May 2012 • Member of Board of directors of Fondazione Instituto Insubrico Ricerca per la Vita Foundation from June 2012 He was specific experience and knowledge on clinical and basic research management and on clinical experimental medicine organization and management
Lecture: Big Data-Big Opportunity for Patient Associations and Clinical Trial Center
Tuesday, 18 October, 15:30 – 15:55 Big data, differently from what many believe, do not regard just the merge of many registries and clinical Databases, nor the establishment of new unified single repositories, into which clinicians and their institutions can transmit large sets of structured data, collected by means of standardized forms. Big data, by definition, regard: very large amount of data (which could only be partially the case of many forms collected together); data that change or are acquired quickly (not only few times a day or weeks); and most importantly a great variety of data. This means that structured data are only one small portion of the data that people call big; a common place in the IT discourse runs that unstructured (i.e. untyped data) data are the “other 80 percent of all data”: in other words, it is unstructured whatever is not in a databases. Unstructured data usually encompass sensor data; text-based practice guidelines and health product information; scientific publications and case reports; as well as (health-related) content produced by people within their favorite social media (also unaware of doing it); clinical imaging resources; and, last but not the least, the free-text areas and comments contained in any electronic medical record. The emphasis (and economic investment) on the big data can, almost unintentionally, allow for a renovated appreciation of the “small data”, especially the totally unstructured ones, that are produced, annotated and consumed locally at the doctor office. The latest achievements in data mining and pattern recognition do have a potential to improve the doctors’ ability to leverage the patients’ accounts of their history and symptoms, and it could be included in secondary outcomes of clinical trials. Personalized medicine aims to trace medical evidences an recommendations back to the “particular person” instead of considering average classes of “similar” patients (cf. the diagnosis-related groups introduced in the medical discourse 35 years ago). This medicine is enabled by big data analytics and current data mining and pattern recognition techniques when these are coupled with a comprehensive datafication of the patient characteristics. Personalized medicine absolutely needs big data. The “in one clinical trials” need big data to achieve success. EU in proposing “big data” as a horizontal theme for all biomedical topics. Big data should be fundamental for improving clinical trials, especially to avoid unnecessary experimental phases, to cut long times elapsed from the start of recruitment of patients and first elaboration of data, and to emphasize “in silico trails”.
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Moreover, big data should be crucial for evaluating continuous biomedical data and findings, e.g. by point of care or wearable sensors, and for mimicking “real-life” conditions during the experimental phase for drugs, medical devices, probiotics and procedures. Big data could be obtained by laboratory medicine and additional diagnostic repositories (imaging): the standardization of procedures to achieve data is mandatory. Living lab could be a common place for hospital experimental trials. We could present some experiences of San Raffaele and Galeazzi, concerning/including robotics, PROMS, registries, role of nurses.
Dr. Martine Dehlinger-Kremer
Vice President Global Medical and Regulatory Affairs, SynteractHCR; Chair of the Paediatric Working Group, EUCROF Dr. Martine Dehlinger-Kremer has nearly 30 years of experience in the clinical research industry. including more than 25 years of progressively higher levels of Regulatory and Medical Affairs leadership responsibility. For 21 years, she served as a vice president of International and Global Regulatory Affairs and Global Medical Affairs at various CROs headquartered in the U.S. Dr Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars, from early development stages through clinical studies and final registration. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) in local and common technical document format, electronic common technical document (eCTD) and NeeS format; in the maintenance of products on the market and in numerous clinical studies across all phases. Dr. Dehlinger-Kremer has seen the evolution in complexity of trials and the impact of global trials on innovation. She has served as Chair of the Paediatric Working Group of EUCROF (the European CRO Federation) since 2008 and has influenced the standards, protocols and number of trials conducted for drugs being administered to children. Dr. Dehlinger-Kremer is also Member of Working Parties of Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) and Member of Children’s Medicines Working Party of EFGCP (European Forum for Good Clinical Practice). Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015. Dr. Dehlinger-Kremer holds a doctorate in sciences from the University of J.W. Goethe in Frankfurt, a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France, and a Master of Science from the University Moulin de la House in Reims, France.
Lecture: Feasibility and Challenges with Paediatric Clinical Trials
Tuesday, 18 October, 12:05 – 12:30 Despite improvement, drug development of medicines for children is still lagging behind the development of drugs for adults. Between 50 and 90 % of daily prescriptions for sick children use “off label” drugs, agents which have not been tested for safety and efficacy in the paediatric population. Consequently, there is insufficient information about dosage, safety and efficacy. This means that child health care providers lack the basic scientific data that they need to be able to make informed judgments for their paediatric patients, a situation that is considered unacceptable for adults. Indeed, an increased risk of adverse drug reactions and ineffectiveness of particular drugs have been demonstrated, due to the use of off-label or unlicensed drugs in children. Extrapolation of adult to child data is problematical for several reasons. Pharmacokinetic (PK) and pharmacodynamic (PD) processes in children differ considerably from those in adults. In addition, the paediatric population cannot be considered as a homogeneous group. Different age-groups that have their own PK- and PD-particularities have been defined: “pre-term newborns“
